Bosulif

Medicinal product

(Invented) name

Bosulif

Active substance (s)

Bozutinibas

Strength

400 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EA04, bosutinib

Marketing authorisation holder

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2013-03-27

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Bozutinibas	400 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
101944	88046	1088046	lizdinė plokštelė	N28		Receptinis	EU/1/13/818/006	Netiekiama	-	-	No	-	-
101945	88047	1088047	lizdinė plokštelė	N30		Receptinis	EU/1/13/818/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-03-27	Registruotas